DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award | HT942524ALSRPPCTA

Opportunity Information: Apply for HT942524ALSRPPCTA

The FY24 DOD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award is a Department of the Army (USAMRAA) grant opportunity designed to push promising ALS interventions into early clinical testing quickly. The main goal is to rapidly launch pilot clinical trials that could materially change how ALS is treated or managed, even if the intervention is not ready for approval by the end of the award. The program is specifically aimed at generating the kind of early human evidence that reduces risk and sharpens the design of later, larger studies, or that produces near-term improvements in clinical care and symptom management for people living with ALS.

This award is strictly for clinical trials, meaning a prospective study where participants are assigned to one or more interventions (including placebo or control conditions) to measure biomedical or behavioral health-related outcomes. In practice, that means the funding cannot be used for preclinical-only projects, observational studies, or efforts that do not measure safety, effectiveness, and/or efficacy outcomes tied to an intervention. Trials supported under this mechanism can range from phase 1 to small, early phase 2 studies, with an emphasis on practical learning objectives such as safety, feasibility, biomarker use, and preliminary signals of therapeutic benefit in relevant ALS patient populations.

Eligible projects include studies of drugs, biologics, and devices that have a strong scientific rationale backed by preliminary studies and/or preclinical data, as well as trials focused on improving patient care or symptom management. A major distinguishing requirement is that any project proposing a therapeutic intervention (drug, biologic, or device) must incorporate biomarkers that are specific to that intervention. Applicants are expected to lay out a clear biomarker-driven strategy and explain how those biomarker results will de-risk the program and inform the next-stage trial design. The announcement explicitly recognizes several biomarker categories, including target engagement markers (showing the therapy hits its intended target), pharmacodynamic markers (showing a biological effect of the therapy), and predictive or cohort-selective biomarkers (helping identify which patients or subgroups are most likely to benefit).

The program defines impact in a very pragmatic way: success is measured less by whether the intervention is "ready" at the end of the pilot trial and more by whether the results will meaningfully accelerate future trials or improve care. The scope can be tailored to specific ALS subpopulations, and in some cases may even focus on outcomes relevant to very small cohorts or individual patients, as long as the work clearly supports forward progress toward better trials or better care.

A central, non-optional feature of this mechanism is required community collaboration. Every application must include at least one community partner, such as a person living with ALS, a family member or caregiver, or a representative of a community-based organization. The intent is that community members are not token advisors; they should be integrated throughout planning and implementation in an ongoing, equitable way, shaping aspects such as needs assessment, trial design, recruitment and participant experience, implementation, evaluation, and dissemination. The solicitation highlights multiple acceptable models, including embedding a person with ALS or caregiver as an advisor, building a partnership with an advocacy or service organization, or creating a broader community advisory board.

Operational readiness is emphasized. The proposed trial is expected to start within 12 months of the award date, or within 18 months for FDA-regulated studies. Applications must document that the investigational product or device (and any other required materials) will be available and accessible for the full study duration. Applicants also need to demonstrate realistic access to a suitable study population and present a credible accrual plan, including a strategy for appropriate inclusion of women and minorities aligned with the trial objectives.

The solicitation places strong expectations on the team, infrastructure, and regulatory competence needed to run a real clinical trial. Applications should show that personnel have expertise in clinical trial conduct, statistical analysis, FDA processes where relevant, and data management. A study coordinator (or coordinators) is expected to be in place to shepherd the protocol through IRB review and any additional regulatory approvals, coordinate multi-site activities, and manage participant recruitment. Where FDA-regulated, the applicant should also show institutional support and, if applicable, readiness to serve as the FDA regulatory sponsor and fulfill sponsor responsibilities under 21 CFR 312.

Strong trial methods and data integrity are required. Applicants must provide a clear statistical analysis plan, a power analysis that justifies the proposed sample size in relation to the study objectives, and a data management plan using an appropriate database to protect data quality and integrity. For FDA-regulated trials, the database must be 21 CFR 11-compliant and align with appropriate data standards, reflecting the expectation that the trial will generate evidence usable for subsequent regulated development.

Finally, the award expects investigators to plan beyond the pilot. A transition plan is required, describing how a successful project would move to the next trial phase and/or influence standards of care, including likely funding paths and resources needed. Awardees must also participate in annual virtual In Progress Review milestone meetings to present progress toward goals, and the program encourages including community partners in these updates. From an administrative standpoint, the opportunity is listed as HT942524ALSRPPCTA under CFDA 12.420, offers grant funding through USAMRAA, is open to unrestricted applicants, had an original closing date of July 10, 2024, and anticipated making about three awards (with the award ceiling not specified in the provided text).

• The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on 2024-03-25.
• Applicants must submit their applications by 2024-07-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 3 candidate(s).
• Eligible applicants include: Unrestricted.

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